Summary:

Provides procedures for investigating and identifying causes for discrepancy occurrences. Includes provisions for recommending appropriate corrective action and assuring the corrective action is implemented in a timely fashion, closing out Discrepancy Reports by verifying the implemented corrective action satisfies the requirements of the corrective action identified on an approved Discrepancy Report, filing, tracking and monthly summary reports.

Included Sections:

Purpose, Scope, Responsibility, References and Applicable Documents, Materials and Equipment, Health and Safety Considerations, Documentation Requirements, and Procedures

Included Attachments/Appendices:

Discrepancy Report Form, Environmental Monitoring Discrepancy Report Form, Notice of Discrepancy Report Cancellation

About This Document:

This is not a generic template, it's a 13-page procedure that was actually created and used in the Quality Assurance operations of a FDA-regulated establishment. The company-specific information (names, addresses, some images, proprietary product information, etc.) has been redacted but the content and format have been largely preserved.

Reasons to Buy:

• Use it as a starting point for your own documentation project
• Compare the quality of your documents against your industry peers
• Learn what other companies in your industry are actually doing

Who Will Benefit:

• Quality Assurance Managers
• Manufacturing Managers
• Quality Control Personnel